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Sitagliptin in the Elderly

This study is currently recruiting participants.
Verified February 2012 by University of British Columbia
Sponsor:
Collaborator:
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00451113
First received: March 21, 2007
Last updated: February 28, 2012
Last verified: February 2012
History of Changes
  Purpose

Diabetes is common in the elderly; by the age of 70, approximately 25% of the population will have diabetes. Unfortunately, currently available medications are often not as effective or not well tolerated in older adults. Sitagliptin is a new medication in a new class of agent called incretins. Incretins have many potential advantages for the treatment of diabetes in the elderly. They stimulate insulin secretion, which is impaired in all older people with diabetes. The incidence of hypoglycemia with currently available medications increases with age, and incretins rarely cause hypoglycemia . They assist with weight loss, whereas many current medications used to manage diabetes result in weight gain in the elderly. They improve insulin action, and insulin resistance is a major problem in older people with diabetes.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Sitagliptin 100 mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Sitagliptin in the Elderly

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Safety and efficacy of Sitagliptin in an elderly population with type 2 diabetes [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sitagliptin 100 mg
    All subjects will receive a single 100 mg dose of sitagliptin and a placebo. Which they are given first is determined randomly.
    Other Names:
    • Januvia
    • MK-0431
    • Dipeptidyl peptidase IV inhibitor (DPP-4 inhibitor)
Detailed Description:

To date, no clinical trials have been conducted specifically in the elderly, but the data noted above from our laboratory would imply that inhibitors of this enzyme could be more effective in the elderly patient population. In addition, we have convincingly demonstrated that diabetes in the elderly is metabolically distinct from diabetes in middle aged patients (1). Thus, it is clear further studies are warranted to determine the effectiveness of drugs in this class in elderly patients with diabetes. We propose a series of studies with your DP4 inhibitor sitaglipitin to determine its efficacy and safety in an elderly patient population with diabetes.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes managed by diet or metformin only
  • A1c < 8.5%

Exclusion Criteria:

  • treated with insulin or oral agents other than metformin in the past 6 months
  • evidence of diabetic complications including coronary artery disease, stroke, transient ischemic attacks, peripheral vascular disease, nephropathy, retinopathy, or neuropathy
  • type 1 diabetes or a history suggestive of a secondary causes of diabetes
  • A1c ≥ 8.5%
  • participated in another clinical trial within the past 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451113

Contacts
Contact: Chris Lockhart 604-875-4111 ext 68535 lockhart@interchange.ubc.ca

Locations
Canada, British Columbia
University of British Columbia Gerontology & Diabetes Research Centre Recruiting
Vancouver, British Columbia, Canada
Contact: Chris Lockhart     604-875-4111 ext 68535     lockhart@interchange.ubc.ca    
Principal Investigator: Graydon Meneilly, MD            
Sponsors and Collaborators
University of British Columbia
Merck Frosst Canada Ltd.
Investigators
Principal Investigator: Graydon Meneilly, MD University of British Columbia
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00451113     History of Changes
Other Study ID Numbers: H06-03067
Study First Received: March 21, 2007
Last Updated: February 28, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Type 2 diabetes
Older adults
Incretins
Hyperglycemia
Insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013